MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U357574
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicates that model u357574 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from various source.Two patients involved with no reported patient injury.One patient was female, remaining patient's age, weight, and gender were not provided.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10309801
• Report Number: 2020394-2020-04944
• Device Sequence Number: 16358827
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: U357574
• Device Catalogue Number: U357574
• Device Lot Number: CMCP0072, CMDT0048
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1